EC approves Moderna RSV vaccine for people over 60

Compilation
modern announced that the European Commission (EC) has granted marketing authorization to mRESVIA (mRNA-1345), its mRNA vaccine against respiratory syncytial virus (RSV). The vaccine is intended to protect adults over 60 years old against lower respiratory tract diseases caused by this infection.

The marketing authorisation is in line with the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The authorisation valid in 27 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.

Health Commissioner Stella Kyriakides stressed the importance of innovation in protecting public health and welcomed the progress as an example of the EU’s commitment to ensuring access to vaccination.

This permission is made by mRESVIA First messenger RNA vaccine approved in the EU for a disease other than Covid-19. It also joins other RSV vaccines authorised by the EU last year to protect vulnerable groups such as infants. The Health Commissioner, Stella Kyriakidesstressed the importance of innovation in protecting public health and welcomed this progress as an example of the EU’s commitment to ensuring access to vaccination.

We are talking about First vaccine with messenger RNA technology approved in the EU for a disease other than coronavirus, following a positive assessment by the EMA last June. Brussels also authorized the use of other respiratory syncytial virus vaccines last year to protect vulnerable groups, including infants.

“Vaccinations save lives. In a strong European Health Union, we are determined to ensure that everyone has access to the protection they need against serious diseases.”

“Vaccinations save lives. In a strong European Health Union, we are determined to ensure that everyone has access to the protection they need against serious diseases.”– assured the health commissioner, who regarded the approval of the first vaccine based on messenger RNA as an example “The importance of innovation when it comes to protecting the health of citizens.”

“The approval of mRESVIA by the European Commission is an important milestone for public health and underlines Moderna’s leadership in mRNA. This approval represents the first authorisation of an mRNA vaccine against a disease beyond Covid-19 in Europe.“he stated Stephane BancelCEO of Moderna.

In the EU, the virus is estimated to cause around 160,000 adult hospitalisations each year.

“mRESVIA protects older adults from serious complications caused by RSV and is uniquely offered in pre-filled syringes for ease of administration, which may reduce vaccine preparation time and reduce administrative errors.”– he explained.

RSV is a highly contagious seasonal respiratory virus and a major cause of lower respiratory tract infections and pneumonia. The disease burden is particularly high in infants and the elderly. In the EU, the virus is estimated to cause approximately 160,000 hospitalizations among adults every year, of which 92% occur in older people 65 years old.

“This approval represents the first authorisation of an mRNA vaccine against a disease beyond Covid-19 in Europe.«

The commercial approval of mRESVIA is based on Positive data from phase 3 clinical trial of ConquerRSVa global study involving approximately 37,000 adults aged 60 years and older in 22 countries. The primary analysis, with a median follow-up of 3.7 months, found vaccine effectiveness (VE) against RSV lower respiratory tract disease (LRTD) of 83.7 percent (95.88% CI: 66.0%, 92.2%), the results were published in The New England Journal of Medicine.

In an additional analysis with a median follow-up of 8.6 months, mRNA-1345 demonstrated durable efficacy with an efficacy rate of 63.3 percent (95 percent CI: 48.7 percent, 73.7 percent) compared with RSV ETRI including two or more symptoms. Efficacy was 74.6 percent (95 percent CI: 50.7 percent–86.9 percent) compared with RSV ETRI with two or more symptoms including shortness of breath, and 63 percent (95 percent CI: 37.3 percent–78.2 percent) compared with RSV ETRI with three or more symptoms.

The study’s statistical criteria remained stringent: the lower limit of the 95% CI was greater than 20%, consistent with both endpoints. The most common adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory tract disease caused by VRS infection. The approval was granted under breakthrough therapy designationbeing the second one received by Moderna.